FDA.reportPublic FDA data

Cefuroxime Axetil

Product NDC
50090-4153
11-digit product format
500904153
Labeler code
50090
Product ID
50090-4153_3b6c7e6f-dcfd-4ef3-b3bb-c129de464f09
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefuroxime Axetil
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065308
Marketing category
ANDA
Marketing start
2006-03-29
Substance
CEFUROXIME AXETIL
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cefuroxime Axetil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFUROXIME AXETIL500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZ49QDT0J8Z
Rxcui309098

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba66f2a7-7ba5-e81a-8863-a38bd5c2e969Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4153-02023-01-30C16284748780-1f386c649-aae4-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CEFUROXIME AXETIL TABLETS safely and effectively. See full prescribing information for CEFUROXIME AXETIL TABLETS. CEFUROXIME AXETIL tablets, for oral use Initial U.S. Approval: 1987
50090-4153-02023-01-30C16284748780-1f386c649-aae4-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CEFUROXIME AXETIL TABLETS safely and effectively. See full prescribing information for CEFUROXIME AXETIL TABLETS. CEFUROXIME AXETIL tablets, for oral use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4153-0Cefuroxime Axetil20 in 1 BOTTLETABLET204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4153-0EA - Each50090-4153e268f81b-16be-4360-a66e-f5fc5afdddbd12025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4153CEFUROXIME AXETIL TABLET [A-S MEDICATION SOLUTIONS]2Current NDC, Legacy NDC, 1 package rows20190228_aa6685c1-51ed-466a-ae7f-89a82986a7b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309098cefuroxime axetil 500 MG Oral TabletPSNaa6685c1-51ed-466a-ae7f-89a82986a7b14
309098cefuroxime 500 MG Oral TabletSCDaa6685c1-51ed-466a-ae7f-89a82986a7b14
309098cefuroxime (as cefuroxime axetil) 500 MG Oral TabletSYaa6685c1-51ed-466a-ae7f-89a82986a7b14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4153-05009041530020 TABLET in 1 BOTTLE (50090-4153-0) 20 tablet2019-02-220000-00-00NoNoCurrent